MAUDE Adverse Event Report: YUKON MEDICAL, LLC 20MM SMARTSITE VENTED VIAL ACCESS DEVICE

Model Number MV0420-0006

Device Problem Device Operational Issue (2914)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/04/2016

Event Type  malfunction  

Event Description

Note: yukon medical was originally made aware of this reported problem on (b)(6) 2016.The initial information provided to yukon indicated that a user or patient may have been impacted (see details below).Additional correspondence was then provided to yukon medical retracting any impact to a user or patient; therefore, the incident was not reported.At a later date (17may2017), yukon medical was contacted by the competent authority to submit as mir for the reported complaint.An initial (b)(4) was submitted to the competent authority on 17may2017.Yukon was unaware at the time that all eu events were required to be reported to the fda.As a result of an fda inspection completed at our site on 6apr2018, it was communicated by the investigator that eu events need to also be reported in the us if the device is marketed in the us regardless of where the reportable incident occurred.Therefore, yukon medical is reporting the event at this time.This is number two of two events that is being reported.Summary of event of product problem: when capping the drug vial with protector viashield (this was later specified as a vialok device by the user), the plastic spike tip folded, making it impossible to extract the drug from the vial.Details regarding user or patient impact: the initial problem report (b)(4) provided by bd/carefusion customer advocacy indicated a patient had an allergic reaction, however in a follow-up correspondence received from the end-user on the issue it was specified that no drug got on the user or patient.No user or patient harm occurred.No drug was involved because the vial access device spike bent (folded) when capping the vial (attaching the adapter to the vial).

• Brand Name: 20MM SMARTSITE VENTED VIAL ACCESS DEVICE
• Type of Device: 20MM SMARTSITE VENTED VIAL ACCESS DEVICE
• Manufacturer (Section D): YUKON MEDICAL, LLC; 4021 stirrup creek drive; suite 200; durham ND 27703
• Manufacturer (Section G): YUKON MEDICAL, LLC; 4021 stirrup creek drive; suite 200; durham 27703
• Manufacturer Contact: pamela mcnulty ; 4021 stirrup creek drive; suite 200; durham, NC 27703 ; 9195958253
• MDR Report Key: 7427291
• MDR Text Key: 105823897
• Report Number: 3009631669-2017-00001
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K122265
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MV0420-0006
• Device Catalogue Number: MV0420-0006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/04/2016
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1